On Government Sticking Its Nose Into Family Decisions- RE: HPV and Gardasil

On Government Sticking Its Nose Into Family Decisions- RE: HPV and Gardasil

26 January 2007 at 12:54:23 AM

salon

I noticed a bill, HB215, the other day about making it mandatory for girls in the 6th grade to get the HPV vaccine. Immediately my hackles went up, not over whether or not it would be a good idea to get the vaccine, but that government would be taking over a parental role in doing it. And it seems especially ironic when a number of schools are not teaching, in sex ed, protected sex, but abstinence, as if no kid in high school would ever have sex. Condoms, for example, can prevent the risk of HPV-related diseases, but this isn\'t taught in some abstinence classes (abstinence classes, incidentally, are mandated in Texas schools in order to graduate). Seems to me that a well rounded sex class would include some *realistic* views on safe sex, not merely abstinence, as well as some stern information about HPV that would go home to parents to read as well. (Incidentally, let me say again that I think expecting kids to abstain from sex is a nice idea but completely unrealistic; kids should be taught what they can use to prevent pregnancy or disease-like, uh, condoms)

But here\'s the real rub of what gets to me. It\'s when you see Big Pharm behind some of these initiatives or at least aligned with spokespersons who are set to profit. (In the abstinence link, above, the woman who is doing the training for "Worth the Wait" profits from being a consultant for a pharm company). If any person representing any organization is also sponsored by pharmaceutical companies who would profit from mandatory vaccinations for all students, his or her comments, in my view, become suspect.

WIG has also established a "Business Council which it describes as a group which "provide a private sector perspective to our programs" with members playing "an integral role in planning for future growth, have the ability to attend our regional conferences, and support the financial stability of the organization." [2] Members are:

Hmmm. Also on that page is the list of sponsors. ON an external link "The Blog That Ate Manhattan", from December 27, 2006, the writer points out that much of the push for Women in Government\'s "Challenge to Eliminate Cervical Cancer" is funded, in large part, by the makers of the HPV test and vaccine.

Here\'s the corporate membership roster of the Council - Digene (makes the HPV test), Merck (HPV vaccine maker), GlaxoSmithKline (HPV Vaccine maker), Wellpoint (heads the council), Exxon Mobile and Verizon. A full 50% of the membership stands to benefit from the legislative efforts of the Challenge to Eliminate Cervical Cancer. And one of the Council\'s members, Digene, has a bit of a sordid past when it comes to partnering with women\'s groups to forward favorable legislation...

In their most recent report, the Challenge to Eliminate Cervical Cancer clearly stated that the publication was made possible by funding from Digene. But on none of its press releases about HPV does the WIG reveal its relationships with Digene, Merck or GlaxoSmithKline.

Pap testing has cut cervical cancer rates by 75 percent or more in nations with thorough screening. In the United States, there are about 10,000 cases of cervical cancer each year and 4,000 deaths. More than half the cases are in women who do not undergo screening.

"It is one of the greatest public health interventions in terms of sheer success and lives saved," said Philip Castle, an expert on cervical cancer screening at the National Cancer Institute.

What about HPV testing?

One problem is that HPV testing costs $50 to more than $100, compared with as little as $20 for a Pap test. More significant, many, if not most, sexually active women will be infected with HPV at some point. But in most cases, particularly for younger women, the immune system dispenses with the virus.

That is why even those who advocate using HPV testing as the primary screen, or using it alongside Pap testing, do so only for women over 30 or 35, when the viral infection is less likely to be transient. (The HPV test is approved for two uses: to help resolve an ambiguous Pap test or to use in conjunction with Pap screening for women 30 and over.)

Does getting that mandatory vaccine protect against HPV? Well... No

It is not that women would no longer need screening because they had been vaccinated. The vaccine, approved only for girls and women 9 to 26 years old, does not protect against all strains of HPV that cause cancer.

Anyway, while I think one of the women quoted in the DMN article is dumb to think her kid only needs abstinence training, at the same time I don\'t like Texas Lege making those vaccines mandatory. What\'s next to nose into family life?

P.S. I did a search on Merck on the Texas Ethics website and noticed that Van de Putte, who is one of the female sponsors of the bill has taken a goodly amount of money from Merck.. who puts out Gardasil. Seems to me that once you take money from Big Pharm, and then propose a mandatory shot, it\'s hard to imagine entirely disinterested or pure motives.

It is important to note that Gardasil may not completely protect anyone, nor has it been shown to protect against diseases associated with the other 26 or more sexually transmitted HPV types or against diseases not caused by HPV. This vaccine does not prevent all cervical cancer cases, making it crucial for women who have (or have not) been vaccinated to continue routine cervical cancer screenings, such as annual pap smears. In addition, Gardasil is not a treatment for cancer or genital warts and is not effective for those who already been infected with HPV (Cerner Multum, Inc.).

Opinions regarding the safety of Gardasil vary among physicians, with many urging for more studies of its side effects. Since the vaccine has been available for about 5 years, there have not been published studies reporting long term side effects of Gardasil. In accordance with the FDA's recommendations, Merck is conducting a study of 44,000 subjects to uncover the short- and long-term side effects of the vaccine (U.S. Food and Drug Administration, "FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers").

Some physicians, including Dr. Joseph Zanga at the Columbus Regional Healthcare System in Georgia and Dr. Jacques Moritz, the director of gynecology at St. Luke's Roosevelt Hospital, believe that current cervical cancer screening techniques (such as the pap smear) and treatment options obviate the need for Gardasil, especially since it does not protect against all HPV strains.

Dr. Joseph Zanga, chief of pediatrics at the Columbus Regional Healthcare System in Columbus, Ga., pointed out that Gardasil does not prevent women from contracting HPV in every instance, that many people who are infected will spontaneously rid themselves of the virus, and that routine pap smears are still the best prevention against cervical cancer.

"Perhaps the most important, currently missing 'warning' is that the vaccine may not be forever," Zanga said. "We know that it protects for 5-7 years so that a girl getting the series at [age] 11-12 will enter the time of her most likely sexual debut unprotected but believing herself to be."

However, others, including Dr. Kevin Ault, the associate professor Gynecology and Obstetrics at Emory University, believe that the benefits of Gardasil outweigh its risks and that the reported adverse side effects are likely not caused by the vaccine (Chitale).

A 2009 editorial in the Journal of the American Medical Association (JAMA) pointed out several flaws of Gardasil that should be considered. Of the 15 oncogenic, or cancer-causing, HPV strains, Gardasil only protects from infection by two of them (HPV types 16 and 18). Consequently, receiving the vaccination does not preclude someone from being infected with a HPV strain and developing cancer (Haug, 2009). Furthermore, since genital warts and lesions are not solely caused by HPV strains 6 and 11, Gardasil does not provide complete immunity from those lesions. For example, a 2011 editorial published in the New England Journal of Medicine reported that in a medical institute in Germany, of 347 men with genital lesions, 38% of them were not infected with HPV strains 6 and 11, indicating that Gardasil most likely would not have protected them from infection (Wieland and Kreuter, 2011). These reports indicate that Merck should try to improve Gardasil to provide immunity against a greater spectrum of HPV strains.

Even if a person receives the Gardasil vaccination at a young age, it has not been shown that this will prevent development of cervical cancer during adulthood. Even though girls and women of ages 9 to 26 can receive the vaccine, cervical cancer is rare in females younger than 30 years of age, as shown in Figure 3; the median age of cervical cancer diagnosis is 47 years (Centers for Disease Control and Prevention, "Cervical Cancer Rates by Race and Ethnicity"). However, Merck has not of yet demonstrated whether receiving Gardasil at an age between 9 and 26 can reduce cervical cancer rates in women of that age group. Furthermore, of the 79% of women who will be infected with HPV, about 90% of women will not develop cervical cancer due to the strength of their natural immune response; as of now, it has not been determined who will actually benefit from the Gardasil vaccination, making it necessary to conduct clinical studies that involve a long-term follow up with those who get vaccinated (Centers for Disease Control and Prevention, "Genital HPV Infection – Fact Sheet"; Haug, 2009).

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